Quality & CSV

Experience: 2 Years

Location: Hyderabad

Employment Type: Full-time

We are seeking a Specialist – Quality & CSV with 2 years of experience to support quality systems and ensure compliance with Computer System Validation (CSV) and regulatory requirements. The role involves maintaining quality documentation, supporting audits, and ensuring validated systems meet GxP standards.

• Support CSV activities including validation plans, protocols, and reports
• Ensure compliance with GxP, FDA, and regulatory guidelines
• Maintain quality documentation (SOPs, deviations, CAPAs, change controls)
• Assist in internal and external audits and inspections
• Review and approve validation and quality documents
• Support risk assessments and system lifecycle activities
• Coordinate with IT, QA, and business teams for validated systems

• 2 years of experience in Quality Assurance and CSV
• Knowledge of GxP, FDA 21 CFR Part 11, and data integrity
• Experience in validation documentation and execution
• Familiarity with QMS processes (deviations, CAPA, change management)
• Good documentation and communication skills

• Experience in pharmaceutical, biotech, or regulated environments
• Knowledge of SDLC and validation lifecycle
• Exposure to audit support and compliance activities